A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis

Launched by ACCRO BIOSCIENCE (SUZHOU) LIMITED · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called AC-101 to see if it is safe and helpful for people with moderate to severe ulcerative colitis, which is a condition that causes inflammation and sores in the large intestine. The study will last about 17 weeks, including a few weeks to check if participants qualify, 12 weeks of taking the medicine, and one week to check safety afterward. About 24 people with active symptoms of ulcerative colitis will take part.

To join the study, participants need to have had ulcerative colitis symptoms for at least three months and meet certain criteria showing their disease is currently active, such as frequent stools and rectal bleeding confirmed by tests. People already taking certain medications for ulcerative colitis may continue them if their doses are stable. During the study, participants will take AC-101 tablets and visit the study center for check-ups. The goal is to learn if AC-101 works well and is safe for people with this condition. If you or a family member have moderate to severe ulcerative colitis and are interested, this study might be an option to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of Ulcerative Colitis (UC) or suspected UC symptom for at least 3 months prior to enrolment and confirmed diagnosis of UC by endoscopic and histopathological examinations during screening.
• * Evidence of active UC defined by modified Mayo score of 5 to 9 points (inclusive) with 3 subscores meeting the followings:
• • 1. Stool frequency (SF) subscore of .≥ 2 points, and
• • 2. Rectal bleeding (RB) subscore of .≥ 1 points, and
• • 3. Endoscopic (ES) subscore of ≥ 2 points (excluding friability), confirmed by screening endoscopy
• • Disease extension of ≥ 15cm from anal verge, confirmed by screening endoscopy
• • Currently using concomitant 5-salicylates (5-ASA) or oral corticosteroid (≤ 20 mg prednisone or equivalent, ≤ 9 mg budesonide MMX or equivalent) should keep stable doses from 2 weeks prior to enrolment till study completion.
• • Biologic-naïve or previous biological treatment for more than 5 half-lives.
• Exclusion Criteria:
• • Previous/current documented diagnosis of Crohn's Disease (CD), indeterminate colitis, severe UC required hospitalization or corticosteroid pulse therapy, ulcerative proctitis, fulminant colitis, ischemic colitis and other intestinal diseases.
• • Previous received 2 or more types of advanced treatment including biologics (e.g., TNF-α antibodies, IL-12/23 antibodies, integrin-α4β7 antibodies) and small molecule (e.g., JAK inhibitors, S1P receptor modulator), and all deemed by investigator as treatment failure.
• • Intravenous/rectal administration of steroids or topical administration of 5-ASA within 2 weeks prior to enrolment; systemic administration of small molecule (e.g., Tofacitinib, Upadacitinib, Ozanimod) within 4 weeks prior to enrolment.
• • Clostridium difficile infection or other enteric pathogen infection within 30 days prior to endoscopy, or positive for Clostridium difficile or other enteric pathogens prior to enrolment.